Takeda Pharmaceuticals has agreed to pay nearly $2.4 billion to settle Actos lawsuits, which may resolve the litigation that alleges the drug maker failed to adequately warn consumers and the medical community about the risk of bladder cancer. 

There are currently more than 8,000 product liability lawsuits pending throughout the U.S. involving allegations that Takeda Pharmaceutical and Eli Lilly withheld information about the link between bladder cancer and Actos side effects.

About half of those cases are pending in the federal court system, with the other half pending in various state courts, including California, Illinois, Pennsylvania and West Virginia.

Plaintiffs’ attorneys serving in leadership roles in the federal litigation confirmed the Actos settlement agreement on April 28, indicating that the deal will go into effect if 95% of individuals involved in the lawsuits agree to opt in. However, many believe it is unlikely that Takeda will cancel the deal if participation is close to the target level.

At a 95% participation rate, Takeda is expected to pay $2.37 billion to resolve the product liability lawsuits. However, at virtually full compliance of 97%, that number would rise to $2.4 billion.

The settlement comes after several juries have returned multi-million dollar awards in individual cases that have gone to trial.

In April 2014, the first federal Actos trial resulted in a $9 billion jury award, after evidence was presented that indicated the drug makers destroyed evidence about the risk of bladder cancer faced by users.

While the U.S. District Judge presiding over the federal litigation later reduced the punitive damage award in the case to $37 million, she indicated that the Supreme Court needs to update rules on what is considered excessive in order to effectively deter large corporations from engaging in the type of bad behavior exhibited by Takeda and Eli Lilly.

Earlier this year, the parties involved in the federal litigation were ordered to begin meeting to discuss settling Actos cases in advance of the next bellwether trial, which was expected to begin in May 2016.

The average payout under the terms of the Actos settlement is expected to be more than $296,000 per case. However, that amount could be reduced based on the individual plaintiff’s age, exposure to other cancer-causing toxins and smoking history.

Takeda indicates that it will take a $2.7 billion charge to pay for the cost of the Actos bladder cancer litigation from its 2014 fiscal year fourth quarter earnings. That includes both the settlement and the company’s legal fees.

The settlement is one of the largest in U.S. history involving drug side effects.

Tags: Actos, Actos Bladder Cancer, Bladder Cancer, Diabetes, Diabetes Drug, Takeda Pharmaceuticals